BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE SERIES 29 OBS10/04

    MDR report key: 2997634 · Received March 11, 2013

    Report

    Report Number
    0001831750-2013-01913
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCORRECT SERIAL NUMBER (B)(4) WAS REPORTED FOR THIS COMPLAINT. THE CORRECT SERIAL NUMBER IS (B)(4). THIS IS A DUPLICATE OF MFR REPORT # 1831750-2012-12758. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1501000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 1831750-2012-12758 FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1501000000 FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA REPAIR WORK ORDER THAT THE SIDE RAIL COULD NOT LATCH UP DUE TO A BROKEN SPINDLE WELD. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Description of Event or Problem · 1

    THIS IS A DUPLICATE OF MFR REPORT # 1831750-2012-12758. THE SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1501000000 REPORTED FOR THIS COMPLAINT WERE ACCIDENTALLY SUBMITTED INTO THE COMPLAINT HANDLING SYSTEM TWICE FOR THE EXACT SAME COMPLAINT INSTANCE. PLEASE REFER TO MFR REPORT # 1831750-2012-12758 FOR FULL REPORTING OF SERIAL NUMBER (B)(4) AND CATALOG NUMBER 1501000000 FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101518 ADVANTAGE SERIES 29 OBS10/04 STRETCHER, WHEELED FPO STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1